Regulatory Affairs Specialist I

:Support and collaborate with clients for the registration of Patheon Monza site as a manufacturer of sterile medicinal productsAssist clients in defining the regulatory strategy for Patheon Monza site registrationWrite and review CTD Module Drug Product for new Marketing Authorizations, variations, renewals, and Clinical Trials Applications (CTAs)Support clients in responding to Regulatory Authorities Deficiency LettersLead interactions with the Legal department and external services for notarization, legalization, and translation activities for Rest of the World registrationsEnsure compliance with Marketing Authorization/CTA requirements in manufacturing processes and testingLead change controls to ensure the registration dossier/CTA content is acknowledged in Patheon Monza site documentationConduct gap analysis before Regulatory Authority Prior Approval Inspections/clinical batch confirmation and identify appropriate corrective actionsProvide regulatory support to ensure compliance with relevant legislations, guidelines, and company policiesSupport and participate in Regulatory Authorities inspectionsAssist Regulatory Affairs Supervisor and Manager in editing reports requested by the EU Regulatory Affairs function and maintain RA databaseRequirements:Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or BiotechnologyConfirmed experience (3 years) in a Regulatory Affairs department for an FDA approved pharmaceutical company, preferably manufacturing sterile productsExpertise in writing/reviewing CTD Module Drug Product for sterile medicinal productsProficiency in EU/US and Rest of the World Submissions and handling documentationFamiliarity with Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA GuidelinesGood written and oral English skillsAnalytical, communicative, and relational attitudesThermo Fisher Scientific is an Equal Opportunity Employer.
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